Symptomatic Gallbladder DiseaseNCT01932216
Cosmesis, Patient Satisfaction and Quality of Life After da Vinci Single Site and Multiport Laparoscopic Cholecystectomy
A study testing Cholecystectomy in people with Symptomatic Gallbladder Disease, run by Intuitive Surgical at 8 sites in 2 countries.
Trial summary
Prospective, randomized , multicenter study comparing cholecystectomy performed with da Vinci Single Site Instruments™ to multi-port (four ports) laparoscopy Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Symptomatic Gallbladder Disease
- What is being tested?
- Cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Sep 2013to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient between ages of 18- 80 year
- Patient with symptomatic gallbladder disease
- Patient willing to participate in this study and able to provide informed consent
Who cannot join
- Patient pregnancy
- Emergency patient
- Patient with acute cholecystitis
- Patient with upper midline visible abdominal scars or keloid
- Presence of umbilical hernia , or prior umbilical hernia repair
- Inability of patients to tolerate Trendelenberg position or pneumoperitoneum
- Patient with cirrhosis
- Patients with mental impairment that preclude giving informed consent
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States7 sites
Dr. Omar Kudsi
Brockton, Massachusetts, 02301
West Suburban Hospital
Elmwood Park, Illinois, 60707
JFK Medical center
Lake Worth, Florida, 33462
Baptist Health South Florida
Miami, Florida, 33173
Huntington Memorial Hospital
Pasadena, California, 91105
Drexel University
Philadelphia, Pennsylvania, 19102
Hillcrest Medical Center
Tulsa, Oklahoma, 74104
About this study
Prospective, randomized , multicenter study comparing cholecystectomy performed with da Vinci Single Site Instruments™ to multi-port (four ports) laparoscopy
Read the detailed description
Prospective, randomized , multicenter study comparing cholecystectomy performed with da Vinci Single Site Instruments™ to multi-port (four ports) laparoscopy.
- The primary objective of this study is to evaluate cosmesis, patient satisfaction and quality of life after robotic- assisted single incision cholecystectomy procedure using da Vinci Single- Site Instruments™ in comparison to a multiport laparoscopic approach.
- The secondary objective of this study is to assess the peri-operative clinical outcomes of robotic- assisted single incision cholecystectomy with da Vinci Single - Site Instruments™ in comparison to a multiport laparoscopic approach.
- The third objective of this study is to evaluate hernia incidence at 1 year and 18 months after surgery
- Conditions
- Symptomatic Gallbladder Disease
- Being tested
- Cholecystectomy
- Keywords
- robotic single-site cholecystectomy, laparoscopic cholecystectomy, cosmesis, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecystectomyProcedure or surgery
Gallbladder removal
| Study group | Role | What they receive |
|---|---|---|
| Single-site robotic cholecystectomy | Active comparator | Single-site cholecystectomy using da Vinci robotic assisted surgery Receives: Procedure: Cholecystectomy |
| Multi-port laparoscopic cholecystectomy | Active comparator | Multi-port cholecystectomy using laparoscopic surgery Receives: Procedure: Cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cosmesis
The primary objective of this study is to evaluate cosmesis, patient satisfaction and quality of life after robotic- assisted single incision cholecystectomy procedure using da Vinci Single- Site Instruments™ in comparison to a multiport laparoscopic approach.
Measured: up to 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionDec 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Symptomatic Gallbladder DiseaseStudies of the same condition, open and under way.
- More trials run by Intuitive SurgicalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intuitive Surgical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01932216
- Sponsor's protocol ID
- ISI-RCTSS-001
- Status last verified
- Oct 2017
- First submitted
- 27 Aug 2013
- Last updated
- 16 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Kudsi OY, Castellanos A, Kaza S, McCarty J, Dickens E, Martin D, Tiesenga FM, Konstantinidis K, Hirides P, Mehendale S, Gonzalez A. Cosmesis, patient satisfaction, and quality of life after da Vinci Single-Site cholecystectomy and multiport laparoscopic cholecystectomy: short-term results from a prospective, multicenter, randomized, controlled trial. Surg Endosc. 2017 Aug;31(8):3242-3250. doi: 10.1007/s00464-016-5353-4. Epub 2016 Nov 18.
PubMed 27864724
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cosmesis, Patient Satisfaction and Quality of Life After da Vinci Single Site and Multiport Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT01932216
- Acronym / sponsor ID
- ISI-RCTSS-001
- Conditions
- Symptomatic Gallbladder Disease
- Keywords
- robotic single-site cholecystectomy, laparoscopic cholecystectomy, cosmesis, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Intuitive SurgicalIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 30 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, randomized , multicenter study comparing cholecystectomy performed with da Vinci Single Site Instruments™ to multi-port (four ports) laparoscopy
Detailed description
Prospective, randomized , multicenter study comparing cholecystectomy performed with da Vinci Single Site Instruments™ to multi-port (four ports) laparoscopy.
- The primary objective of this study is to evaluate cosmesis, patient satisfaction and quality of life after robotic- assisted single incision cholecystectomy procedure using da Vinci Single- Site Instruments™ in comparison to a multiport laparoscopic approach.
- The secondary objective of this study is to assess the peri-operative clinical outcomes of robotic- assisted single incision cholecystectomy with da Vinci Single - Site Instruments™ in comparison to a multiport laparoscopic approach.
- The third objective of this study is to evaluate hernia incidence at 1 year and 18 months after surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-site robotic cholecystectomy | Active comparator | Procedure: CholecystectomySingle-site cholecystectomy using da Vinci robotic assisted surgery |
| Multi-port laparoscopic cholecystectomy | Active comparator | Procedure: CholecystectomyMulti-port cholecystectomy using laparoscopic surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient between ages of 18- 80 year
- Patient with symptomatic gallbladder disease
- Patient willing to participate in this study and able to provide informed consent
Key exclusion criteria (8 listed)
- Patient pregnancy
- Emergency patient
- Patient with acute cholecystitis
- Patient with upper midline visible abdominal scars or keloid
- Presence of umbilical hernia , or prior umbilical hernia repair
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CholecystectomyGallbladder removal | Procedure or surgery | Multi-port laparoscopic cholecystectomy, Single-site robotic cholecystectomy |
Primary outcome
Cosmesis
Time frame: up to 3 months after surgery
The primary objective of this study is to evaluate cosmesis, patient satisfaction and quality of life after robotic- assisted single incision cholecystectomy procedure using da Vinci Single- Site Instruments™ in comparison to a multiport laparoscopic approach.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2017.
- Derived from this study: PubMed 27864724Kudsi OY, Castellanos A, Kaza S, McCarty J, Dickens E, Martin D, Tiesenga FM, Konstantinidis K, Hirides P, Mehendale S, Gonzalez A. Cosmesis, patient satisfaction, and quality of life after da Vinci Single-Site cholecystectomy and multiport laparoscopic cholecystectomy: short-term results from a prospective, multicenter, randomized, controlled trial. Surg Endosc. 2017 Aug;31(8):3242-3250. doi: 10.1007/s00464-016-5353-4. Epub 2016 Nov 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cholecystectomy in people with Symptomatic Gallbladder Disease, run by Intuitive Surgical at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cosmesis (time frame: up to 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01932216, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2017.